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A Simple and Inexpensive Method for Determining Cold Sensitivity and Adaptation in Mice
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A simple technique to evaluate model sensitivity in the continual reassessment method.

Ying Kuen Cheung1, Rick Chappell

  • 1Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York 10032, USA. cheung@biostat.columbia.edu

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|September 17, 2002
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Summary

The continual reassessment method (CRM) ensures safe dosing in cancer trials. This study clarifies when CRM is reliable and evaluates model sensitivity for better dose selection.

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Area of Science:

  • Oncology
  • Biostatistics
  • Clinical Trial Design

Background:

  • The continual reassessment method (CRM) is a standard adaptive trial design for Phase I cancer studies.
  • Determining the maximum tolerated dose (MTD) with acceptable toxicity is crucial for patient safety.
  • CRM's consistency under model misspecification is not guaranteed, impacting dose recommendations.

Purpose of the Study:

  • To interpret the core conditions for CRM consistency in dose-finding.
  • To evaluate the sensitivity of different dose-response models within the CRM framework.
  • To provide a supplementary technique for planning Phase I cancer trials.

Main Methods:

  • Analysis of the mathematical conditions for CRM consistency.
  • Application of the derived conditions to assess model sensitivity.
  • Comparison of the proposed technique with traditional simulation methods.

Main Results:

  • Identified key conditions influencing CRM convergence to the target percentile.
  • Demonstrated that model choice significantly affects the proximity of the CRM recommendation to the target dose.
  • The presented analytical technique serves as a valuable addition to simulation-based trial planning.

Conclusions:

  • Understanding CRM consistency conditions is vital for reliable dose selection in oncology trials.
  • Model sensitivity analysis enhances the robustness of CRM-based dose-finding.
  • The developed method offers a practical tool for optimizing Phase I trial design and execution.